MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK¿ PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number H749236310030

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for analysis.Returned product consisted of the rotablator rotalink plus device.The advancer unit and burr unit were received together.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically and visually examined.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.Functional testing was performed by connecting the advancer to the rotablator control console system.The rotablator system was able to reach optimum speed with no abnormal noise and the burr rotated with no issues.Inspection of the remainder of the device presented no other damage or irregularities.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that the burr speed was unstable.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending (lad) artery.A 1.50mm rotalink¿ plus was selected for use.During preparation outside patient's body, after completing the rotaburr set up, normal rotation was performed to adjust the rotation sped to 200,000rpm.However, it was noted that the rotation speed increased and decreased and unusual sound was heard; thus preparation was discontinued.Then, set up was again checked and normal rotation was performed to adjust the speed outside the body; however, the same issue occurred.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: ROTALINK¿ PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7638594
• MDR Text Key: 112375532
• Report Number: 2134265-2018-05758
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2019
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0021670492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER -MACH1 7FR FL3; GUIDE WIRE - ROTAWIREFLOPPY